Introduction

Gluten Free / FDA

Developments in Europe and the United States:
Gluten-free labeling requirements

In autoimmune diseases caused by gluten (a type of protein found in grains such as wheat, barley, and rye), which are commonly referred to as gluten insensitivity or celiac disease, the affected individual cannot digest gluten, which causes issues such as inflammation of the surface of the small intestine, diarrhea, and vomiting. Symptoms of celiac disease can vary from mild to severe and include fatigue, anemia, diarrhea, abdominal discomfort, weight loss, vomiting, and stomatitis. Celiac disease is common among Caucasians but uncommon in non-Caucasians races. In the United States, it is estimated that 3 million people have severe symptoms and 18 million have mild symptoms, with the prevalence climbing to approximately 1% of the population. There is no treatment for this disease and thus it is currently very important for affected individuals to eat foods that do not contain gluten (gluten-free) as a symptomatic treatment.

Therefore, to protect patients with diseases such as gluten intolerance and celiac disease, the movement to test for and label gluten in food is expanding to food-related companies and public agencies all over the world.

Establishment of gluten-free limits and test kits announced by the FDA

In August 2013, gluten-free labeling regulations were enacted and gluten limits for gluten-free foods were established by the Food and Drug Administration (FDA) of the United States. This was the first time that rules for gluten-free foods had been established in the United States.

These gluten limits, which were based on Codex standards, allow items with gluten content of less than 20 ppm to be labeled as “gluten-free.” The establishment of these evaluation standards made it possible to measure the gluten content of foods and other products and label them accordingly. This was very good news for patients with gluten intolerance and celiac disease.

The enactment of these limits will likely lead to increased interest in gluten-free foods. The gluten-free lifestyle is also attracting the attention of general consumers without gluten-related diseases because it is considered to be healthy and a good diet.

When these limits were enacted, our Wheat/Gluten (Gliadin) ELISA Kit5) was sited on "Gluten-Free Labeling" by the FDA. The FASPEK wheat ELISA kit was originally developed to measure the wheat protein content of food for proper allergy labeling, but it targets the gluten in the wheat and thus is also effective for measuring gluten.

Morinaga Institute of Biological Science began as the biochemical research laboratory of the established Japanese confectionary manufacturer Morinaga & Co. Using our advanced immunoassay technology, we became the first in the world to successfully develop kits that could measure allergens in processed foods in 2005. These kits were designated by the Ministry of Health, Labor, and Welfare and the Consumer Affairs Agency as their official measurement methods, and are highly reliable kits with validated performance that are used by many public agencies. Furthermore, as exemplified by the FDA’s designation of the kits as their testing method, the verified performance of the kits has made them well-received by foreign government agencies as well.